Atrial fibrillation
Conditions
Interventions
Thoracoscopic surgical PVI versus catheter PVI
Sponsors
Amsterdam UMC
Eligibility
Inclusion criteria
Inclusion criteria: - Age is between 18 and 80 years. - Persistent AF as defined following the ESC 2016 Guidelines, evidenced by 1) ongoing AF on the ECG or 2) documentation of AF necessitating cardioversion. - AF documented by ECG or Holter < 1 year ago. - At least one class I or III anti-arrhythmic drug in standard dosage has failed or is not tolerated. - Left atrial volume index = 45 ml/m2 - Legally competent and willing to sign the informed consent. - Willing and able to adhere to the follow-up visit protocol. - Life expectancy of at least 2 years.
Exclusion criteria
Exclusion criteria: - Prior intervention (catheter ablation or minimally-invasive thoracoscopic ablation) for AF. - AF is secondary to electrolyte imbalance, thyroid disease or other reversible or non-cardiovascular causes. - Documentation of CTI dependent atrial flutter - Valvular AF - Paroxysmal AF - Long standing Persistent AF, defined as AF continuously present for longer than 1 year. - Body mass index >35kg/m2 - NYHA class IV heart failure symptoms or left ventricular ejection fraction 38,5 °C). - Known and documented carotid stenosis > 80% - Planned cardiac surgery for other purposes than AF. - Pregnancy or child bearing potential without adequate anticonception. - Requirement of anti-arrhythmic drugs for ventricular arrhythmias. - Presence of intracardiac mass or thrombus (discovery of any thrombus or intracardiac mass after signing of the informed consent will result in withdrawal of the subject from the study) - Co-morbid condition that possesses undue risk of general anesthesia or port access cardiac surgery (in the opinion of the operator). - History of previous radiation therapy on the thorax - Circumstances that prevent follow-up - No vascular access for catheterization. - History of previous thoracotomy. - Factors precluding transseptal puncture for catheterization. Sample size
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Absence of any atrial tachyarrhythmia without the use of antiarrhythmic drugs once a total number of 72 patients with AF recurrences after a single procedure have been reached | — |
Secondary
| Measure | Time frame |
|---|---|
| - Freedom of arrhythmia with or without AAD after a single procedure after one year - Freedom of arrhythmia after 12 months with or without AAD after both procedures - Freedom of arrhythmia after 5 years - Cost-effectiveness of both procedures in isolation, and the combination of both procedures - Quality of life | — |
Contacts
Public ContactJoris de Groot
Amsterdam UMC
Outcome results
None listed